Purpose.The National Center for
Research Resources (NCRR) of the NIH invites applications for COBRE
infrastructure support grants. The objectives of this FOA are to continue
support of infrastructure at Centers of Biomedical Research Excellence (COBRE)
that have received 10 years of funding from NCRR. This FOA is supported through the Institutional Development
Award (IDeA) Program at the National Center for Research Resources (NCRR) of
NIH.

Funds Available and
Anticipated Number of Awards.The NCRR intends to commit
approximately $15 million in fiscal year (FY) 2011 to support this program. It
is anticipated that up to 15 applications will be funded in response to this
FOA. Although the financial plans of the NCRR provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.

Budget and Project Period.An applicant may request a project period of five years and may request direct costs up to, but
no more than, $750,000 per year.

Application Research Strategy
Length:

The overall center organization and management
plan: 12 pages;

The administrative core: 12 pages

The research strategy section for
each research core: 12 pages

The pilot project program: 12
pages.

The page limit of each section includes tables,
graphs, figures, diagrams, and charts. See Table of Page Limits.

Eligible Project Directors/Principal
Investigators (PDs/PIs). Individuals with the
skills, knowledge, and resources necessary to carry out the proposed
research are invited to work with their institution/organization to
develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Number of PDs/PIs. Only one PD/PI may be designated on the application.

Number of Applications. Applicant institutions may submit only one application in response
to this FOA.

Resubmissions. Applicants may submit a resubmission application, but such
application must include an Introduction addressing the previous peer
review critique (Summary Statement). See new NIH policy on resubmission
(amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Renewals.Renewal applications are not
permitted in response to this FOA.

The Institutional Development Award (IDeA)
Program at the National Center for Research Resources of the NIH has endeavored
to stimulate research at institutions that traditionally have not received
significant levels of competitive research funding from the NIH. The IDeA
Program was established for the purpose of broadening the geographic
distribution of NIH funding for biomedical and behavioral research by enhancing
the competitiveness for research funding of institutions located in states in
which the aggregate success rate for grant applications to the NIH historically
has been low. The Centers of Biomedical Research Excellence (COBRE) program launched
in fiscal year 2000 in IDeA-eligible states seeks to augment
and strengthen institutional biomedical research capacity. This is accomplished
by expanding and developing biomedical faculty research capability and
enhancing research infrastructure, including the establishment of core
facilities needed to carry out the objectives of a multidisciplinary,
collaborative program.

COBRE support consists of two
sequential five-year phases. Phase I focuses on developing research
infrastructure and providing junior investigators with formal mentoring and
research project funding to help them acquire preliminary data and successfully
compete for independent research grant support. Phase II is intended to
strengthen the center through further improvements in research infrastructure
and continuing development and support of a critical mass of investigators with
shared scientific interests. After ten years of COBRE support, the centers are
expected to be able to compete successfully for other sources of research
funding, such as program project or center grants from other NIH Institutes and
Centers. The objectives of this FOA (COBRE phase III), are to (1) provide
support for maintaining COBRE research cores developed during phases I and II that
are essential for the continuing conduct of basic, clinical, translational
research, and/or community based research at the institution, and (2) sustain a
collaborative, multidisciplinary research environment by providing support for
research pilot projects and mentoring and training components.

Program

In addition to providing core
services to meet the needs of center research activities, the COBRE
Transitional Center support should encourage and facilitate collaborative
research supported by the IDeA program and other research programs at the
applicant institution and, where applicable, at consortium sites. The center
will provide support to:

The administrative core (mentoring and training components, see
details below)

Core resources and facilities, including core supplies, service
contracts, and key personnel for core management

Equipment upgrades and replacement

Funds cannot be used at
collaborative institutions in non-IDeA states. However, funds may be used in
other IDeA and non-IDeA states for fee-for-service activities that include
activities such as learning new techniques, sample and data analysis, workshops
etc. It is the responsibility of the PD/PI to define an effective partnership
and collaboration. Funds cannot be used for alteration and renovation.

Overall Center Organization and Management Plan: Accomplishments
during the past ten years of support and how requested cores will sustain the
center must be described. Each application must describe an overall strategic
plan to identify the significant scientific opportunities that the center
intends to pursue in the next five years. A summary of the proposed research
of the center participants and the anticipated scientific and core facility
needs of each individual project must be included in the Organization and
Management Plan narrative as needed to describe the programs, but also
summarized in a table. Applications must describe an
administrative core with detailed plans for coordinating and facilitating
research and training activities that are to be supported by the COBRE cores.

Administrative core: The administrative
core should be led by the PD/PI of the center. The components of the core
should identify a program coordinator, an internal steering committee
consisting of the core directors and other faculty to provide ongoing
assessment and evaluation of the progress of the center, and an external
advisory committee (EAC) consisting of 3-4 members to provide external review
of progress and assure collaboration and/or partnership between investigators
within an institution, and among institutions in a state and regionally. The
administrative core should provide a clear plan as to how the Administrative
Core intends to implement and accomplish these functions, including,

Leadership at a
broad level to support quality research through the intellectual and material
resources of the center;

Consultation/mentoring
as required with investigators/users to carry out the proposed research;

Mentoring and
research training for career development of investigators who use the
cores, including, but not limited to the design of research proposals and
experiments, updating knowledge of new research technology, and using
modern research instrumentation. Fund should not be used for graduate
student stipend and postdoctoral training.

Although the COBRE
transitional center awards do not require non-Federal matching funds, applications must include clear
evidence of institutional commitment. The level of institutional commitment may
vary across applicant institutions depending on the availability of institutional
resources. At a minimum, a letter of support from a senior institutional
official (e.g., President or Dean) must outline the commitment of resources and
facilities to support the core center. A strategic plan as to how the cores
can be sustained beyond the requested period of grant support must be provided.

Qualifications and
Responsibilities of the PD/PI: The PD/PI must be an
established biomedical or behavioral research scientist with demonstrated administrative
leadership skills. The PD/PI is responsible for overall direction and
development of the center to support collaborative research efforts within and
across institutions. The PD/PI will resolve disputes arising in the priority of
usage of the core facilities and will be responsible for final budget decisions
with the assistance of the program coordinator. Multiple PDs/PIs are not
allowed. The PD/PI should devote at least 1.2 person months to this
effort. A maximum of 2.4 person months effort may be supported.

Qualifications and Responsibilities
of Program Coordinator: A program coordinator may be designated to
provide day-to-day operational and administrative oversight of the core
facilities, help core directors set work priorities, and coordinate
recommendations for major purchases of supplies, equipment upgrades, technical
support staff, and other budget issues with the core directors and the PD/PI.
The program coordinator should have a broad knowledge of core resources and their management
and application to the projects supported by the Center. He/She should have the ability to assist the PD/PI to oversee, coordinate and support
the Center’s research efforts. The program coordinator may devote up to 2.4 person
months to this effort.

Qualifications and Responsibilities
of Core Directors: The core director must be a scientist with expertise in the
specific area of service that the core provides. The core director will be
responsible for meeting with research investigators, determining which research
projects are qualified to use the core, and set priorities for core usage. The
core director also should provide guidance or training to investigators in the
complex core techniques and methodologies to ensure that the core facilities
are appropriately used. Core directors are responsible for maintaining
state-of-the-art techniques and for recommending updated and/or replacement
equipment, as needed, to the Program Coordinator and PD/PI. Each Core Director
may devote up to 1.2 person months to the cores.

Research Core Facilities: The applicant must demonstrate that each core proposed for support will serve
the scientific needs of biomedical research projects; how each core will benefit
investigators and users; and how the Cores serve and/or improve the research
infrastructure of the institution. Each core description should indicate the
qualifications of personnel selected to manage the core facility and/or plans
to recruit personnel to operate the core, if needed. Furthermore, the PD/PI
should indicate any institutional commitment to support and maintain the
proposed facilities. The applicant should describe the operating procedures of
each core, how state-of-the-art techniques will be maintained, how quality
control will be managed, how disputes concerning core usage will be resolved,
and how research investigators will be trained in the capabilities of the core
and the techniques required best served by the core. As appropriate to the
core, applicants should describe plans for protections of human subjects from
research risks, including data security and privacy protection issues;
inclusion of women, minorities, and children; care and welfare of vertebrate
animals, and management of biohazards.

Sharing research resources among IDeA
programs is strongly encouraged. Applicants should seek to utilize existing
equipment and instrumentation supported by COBRE or IDeA Networks of Biomedical
Research Excellence (INBRE) awards. A table summarizing the existing core
equipment must be included in the application. Requests that appear to be
duplicative of existing equipment or instrumentation, including computational
facilities and related bioinformatics resources, must be appropriately
justified. Core facilities supported through this FOA must not duplicate
currently available facilities at the institution.

It is expected that investigators outside of the
applicant’s institution that utilize the core will provide service fees to the
core. The service fees will offset some of the costs for the specific service
provided. Waivers of the fee-for-service charge may be granted by the PD/PI in
appropriately justified instances.

Research pilot project program: Applicants
may request support for a pilot project program that 1) allows junior or senior
investigators to generate preliminary data for submission of grant
applications; 2) develops new technologies; or 3) achieves other goals, as
defined by the PD/PI that will better position the institution to conduct basic
and clinical research. The proposed pilot project(s) must not overlap with the
ongoing funded project(s). Research plans for the individual research projects
should not be included in the application. Up to $250,000 annually can be used
to support the pilot project program. If such a program is proposed, the
description of the pilot project program should include:

A plan for the solicitation of proposals,
prioritization of the projects and the review of their methodology and research
performance.

The scope of the projects; eligibility
requirements; the limit on the dollars available and the number of years of
support per project.

Oversight and evaluation procedures.

The assurance that all projects supported by
this FOA will comply fully with all applicable federal policies, rules, and
guidelines for research involving human subjects and/or vertebrate animals.

The NCRR intends to commit approximately $10
million to support this activity, contingent upon the availability of funds. An applicant must request a project period of five years
and may request direct costs up to, but no more than, $750,000 per year.

Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds.

Facilities
and administrative costs requested by consortium participants are not included
in the direct cost limitation, see NOT-OD-05-004.

NIH
grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this
FOA.

Any individual
with the skills, knowledge, and resources necessary to carry out the proposed
research is invited to work with his/her institution to develop an application
for support. Individuals from underrepresented racial and ethnic groups as well
as individuals with disabilities are always encouraged to apply for NIH
support.

Number
of Applications.Institutions/organizations
may submit only one application per COBRE center in response to this FOA.

Resubmissions.Applicants may submit a resubmission application, but such
application must include an Introduction addressing the previous peer review
critique (Summary Statement). Beginning with applications
intended for the January 25, 2009 official submission due date, all original
new applications (i.e., never submitted) are permitted only a single amendment
(A1). See new NIH policy on resubmission (amended) applications
(NOT-OD-09-003, NOT-OD-09-016). Original
new applications that were submitted prior to January 25, 2009 are permitted
two amendments (A1 and A2). For these “grandfathered” applications, NIH
expects that any A2 will be submitted no later than January 7, 2011, and NIH
will not accept A2 applications after that date.

Renewals.Renewal applications are not permitted
in response to this FOA.

Applications
must have a D&B Data Universal Numbering System (DUNS) number as the
universal identifier when applying for Federal grants or cooperative
agreements. The D&B number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dnb.com/us/. The D&B number should
be entered on line 11 of the face page of the PHS 398 form.

The title and
number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box
must be checked.

3. Submission Dates and Times

Applications must be received on or before
the receipt date described below (Section IV.3.A.).

Applications
must be prepared using the research grant application forms found in the PHS
398 instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and three
signed photocopies in one package to:

Applications must be received on or before the application receipt/ date(s) described above (Section IV.3.A.). If an application is
received after that date, it will not be reviewed.

The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial merit review unless the
applicant withdraws the pending application. The NIH will not accept any
application that is essentially the same as one already reviewed. However, the
NIH will accept a resubmission application, but such application must include
an Introduction addressing the critique from the previous review.

All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy
Statement.

Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new award if such costs: 1)
are necessary to conduct the project, and 2) would be allowable under the
grant, if awarded, without NIH prior approval. If specific expenditures would
otherwise require prior approval, the grantee must obtain NIH approval before
incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a
new award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project
(see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission
Requirements

An
application for a COBRE phase III must include the following sections and
follow the page limits.

Overall Center Organization and Management Plan (12 pages):

A description of accomplishments in the past
ten years of COBRE support.

An overall strategic plan to identify the
significant scientific opportunities that the center intends to pursue in the
next five years.

A clear description of how requested cores
will sustain the center and how the cores will be supported beyond COBRE phase
III.

Administrative core
(12 pages):

A clear and full explanation of the administrative plan
as to how the core intends to implement and accomplish the proposed activities,
including the leadership at a broad level to support quality research through
the intellectual and material resources of the center; consultation/mentoring
as required with investigators/users to use the cores to carry out the proposed
research; and mentoring and research training for career development of
investigators who use the cores, including, but not limited to the design of
research proposals and experiments, updating knowledge of new research
technology, and using modern research instrumentation.

A description of the qualifications and
responsibilities of the PD/PI, program coordinator, and core directors.

A description of the existing infrastructure and
institutional support.

Describe the institutional plans that support
compliance with Protections of Human Subjects and Care and Welfare of
Vertebrate Animals involved in research.

An evaluation plan for the performance of
each core.

Research
cores (12 pages for each core)

A description of the purpose of the core and
justification for the proposed core service facilities that will contribute to
the institutional research.

A brief description (no more than one page
per core) of scientific projects supported.

Description of the core directors and staff
involved in the management and maintenance of the core, specifying the role in
the core.

Description of the operating procedures of
the core, how state-of-the-art techniques will be maintained, how quality
control will be managed, and how research investigators will be trained in the
capabilities of the core and the techniques required to best use the core.

As appropriate to the core, applicants should
describe plans for protections of human subjects from research risks, including
data security and privacy protection issues; inclusion of women, minorities,
and children; care and welfare of vertebrate animals, and management of
biohazards.

Research
pilot project program (12 pages):

A plan for the solicitation of proposals,
prioritization of the projects, and the review of their methodology and
research performance.

The applicant plans for defining the scope of
the projects; eligibility requirements; the limit on the dollars available; and
the number of years of support per project.

Governance, oversight, and evaluation
procedures.

Process(es) in place to assure that all
projects supported by awards issued under this FOA will comply fully with all
applicable federal policies, rules, and guidelines for research involving human
subjects and/or vertebrate animals.

Research plans for the individual pilot projects
should not be included in the application.

Applicants
should follow the order of content described in the current PHS
398 document instructions and indicated on the
Table of Contents page unless noted otherwise below:

A customized Table of Contents page may be
included to indicate the start pages for major sections of the application.

With respect to specific sections, the Budget
section should begin with the summary or composite budget for the center,
followed by the individual budgets for cores, consortia and contractual
arrangements. Do not separate the individual core budgets into each core
section.

All Biographical Sketches should be grouped
together with the PD/PI's biographical sketch presented first followed by all
other biographical sketches in alphabetical order. Each biographical sketch is
limited to no more than four pages, using the NIH format. Do not separate the
biographical sketches into each core section.

Although a PHS 398 face page should not be
used for each individual core, a cover page should be included that indicates
the core title and the name of the core director and whether the core will
involve research involving human subjects and/or vertebrate animals. The cover
page is not counted against the page limit. A Description page that provides
an Abstract of the proposed core is required and should immediately precede
each core description. As necessary, each core section can be concluded with
letters of commitment from collaborators and/or consultants.

A cover page for the pilot project progam
indicating the name of program director and an abstract of the proposed program
should also be provided.

Consecutively number the pages throughout the
application. Do not include unnumbered pages and do not use suffixes, such as
5a, 5b, etc. Adhere to NIH format described in the PHS 398 instructions for
font, line spacing and margins.

Letters indicating institutional commitment
and any letters of support for the proposed center (if applicable). There is no
page limit for this section.

Applicants
submitting a revised application must include an Introduction that summarizes
the substanitial additions, deletions, and changes. The Introduction must
include responses to the criticisms and issues raised in the Summary
Statement. The Introduction is limited to one page for each section. Each
research core comprises a separate section. Insert the Introduction just
before the very beginning of the Research Strategy. Identify within the
Research Strategy the changes made by clearly bracketing, indenting, or
changing typography, unless the changes are so extensive as to include most of
the text. This exception should be explained in the Introduction. Do not
underline or shade changes.

Appendix
Materials

No appendix
material is allowed.

Resource Sharing
Plan(s)

NIH
considers the sharing of unique research resources developed through
NIH-sponsored research an important means to enhance the value of, and advance,
research. When resources have been developed with NIH funds and the associated
research findings published or provided to NIH, it is important that they be
made readily available for research purposes to qualified individuals within the
scientific community. If the final data/resources are
not amenable to sharing, this must be explained in Resource Sharing section of
the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(b) Sharing Model Organisms:
Regardless of the amount requested, all applications where the development of
model organisms is anticipated are expectedto include a description
of a specific plan for sharing and distributing unique model organisms and
related resources, or state appropriate reasons why such sharing is restricted
or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a
genome-wide association study are expected to provide a plan for
submission of GWAS data to the NIH-designatedGWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. A genome-wide association study is defined as
any study of genetic variation across the entire genome that is designed to
identify genetic associations with observable traits (such as blood pressure or
weight) or the presence or absence of a disease or condition. For further
information see Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide
NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application
Review Information

1.
Criteria

Only the review criteria
described below will be considered in the review process.

2.
Review and Selection Process

Review Process

Applications
that are complete will be evaluated for scientific and technical merit by an
appropriate scientific review group convened by NCRRand in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As
part of the scientific peer review, all applications will:

Undergo
a selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of
applications under review, will be discussed and assigned an
impact/priority score.

Receive
a written critique.

Receive a second level
of review by National
Advisory Research Resources Council.

The mission
of the NIH is to support science in pursuit of knowledge about the biology and
behavior of living systems and to apply that knowledge to extend healthy life
and reduce the burdens of illness and disability. As part of this
mission, applications submitted to the NIH for grants or cooperative agreements
to support biomedical and behavioral research are evaluated for scientific and
technical merit through the NIH peer review system.

Overall Impact

Reviewers
will provide an overall impact/priority score to reflect their assessment of
the likelihood for the project to exert a sustained, powerful influence on the
research field(s) involved, in consideration of the following five scored
review criteria, and additional review criteria (as applicable for the project
proposed).

Scored Review Criteria

Reviewers
will consider each of the five review criteria below in the determination of
scientific and technical merit, and give a separate score for each core.
An application does not need to be strong in all categories to be judged likely
to have major scientific impact. For example, a project that by its nature
is not innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical
barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change
the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Do the existing core resources and facilities
serve the scientific needs of the research projects? For requests of new core
facilities: is the request well justified in terms of the need for the core?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited
to the project? If Early Stage Investigators or New Investigators, or in
the early stages of independent careers, do they have appropriate experience
and training? If established, have they demonstrated an ongoing record of
accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

Leadership: Does the PD/PI have the ability
to provide scientific and administrative leadership and direction? Has the PD/PI
shown effective leadership and judgment in the selection of research cores in
terms of the cores being related to and consistent with the overall goals of the
center? Has the PD/PI presented a plan to develop and maintain core
laboratories as state-of-the-art through the selection of appropriate Core
Directors?

Program coordinator/manager: Does the program
coordinator manager have knowledge of core resources and their application to
the projects supported by the Center? Has he/she demonstrated an ability to
oversee and coordinate research activities?

Core Directors and Core Personnel: Do the
core laboratory directors have the scientific and technical experience to
manage their core facility? Has he/she demonstrated expertise in the core
technologies by specific training and/or publications using such methods and
equipment? Has he/she demonstrated the capability to work with many
investigators across departments and institutions? Does he/she have experience
in mentoring and research training for the career development of investigators
who use the cores? Are the personnel who manage the core facilities as well as
the technical staff well qualified?

Innovation. Does the application challenge and seek
to shift current research or clinical practice paradigms by utilizing novel
theoretical concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies,
instrumentation, or interventions novel to one field of research or novel in a
broad sense? Is a refinement, improvement, or new application of
theoretical concepts, approaches or methodologies, instrumentation, or
interventions proposed?

Approach. Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the
project? Are potential problems, alternative strategies, and benchmarks
for success presented? If the project is in the early stages of
development, will the strategy establish feasibility and will particularly
risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Administrative Core: Is the administrative
core adequate to coordinate and facilitate the research, mentoring, and
training supported by the COBRE cores? Are there adequate plans describing the
routine daily operation of the core facility and the quality control methods
for the facility? Are plans in place to ensure adequate methods for resolution
of disputes of core usage and for methods to maintain the core as a
state-of-the art facility? Are plans adequate to prioritize and evaluate
requests for replacement or upgrade of core equipment? Are there adequate plans
for training of research investigators and their staff in the techniques appropriate
for optimal use of the core facility? Is the plan adequate to identify the
internal steering committee, and external advisory committee
(EAC), to
provide ongoing assessment and evaluation of the operations of the cores? Is
there an adequate plan in place to evaluate core performance?

Pilot Project Program: Are there adequate institutional
plans and procedures to solicit proposals, prioritize the projects, assure
compliance with applicable federal policies and guidelines for research and
research protections, and to review their methodology?

Environment. Will the scientific environment in which the
work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit
from unique features of the scientific environment, subject populations, or
collaborative arrangements?

Has the PD/PI obtained institutional
commitment ensuring the resources and facilities required to sustain the cores during
and after the period of support by this program?

OverallCenter Organization and Management Plan: Does the overall plan justify continued
support of the proposed cores for the COBRE for an additional five years? Does
the application describe the institutional environment and resources available
to investigators, and indicate how prior COBRE support has improved facilities
or made available new and collaborative resources?

If support
for instrumentation to augment existing or establish new core facilities is
requested, does the application identify the needs of each component research
project for the core(s) and how this instrumentation will facilitate the
centers research?

Has the PD/PI
selected a suitable External Advisory Committee and has he/she made effective
use of this committee to achieve the objectives of the center?

Additional Review Criteria

As applicable
for the project proposed, reviewers will consider the following additional items in the determination of scientific and
technical merit, but will not give separate scores for these items.

Protections
for Human Subjects. For research that
involves human subjects but does not involve one of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate the
justification for involvement of human subjects and the proposed protections
from research risk relating to their participation according to the following
five review criteria: 1) risk to subjects, 2) adequacy of protection against
risks, 3) potential benefits to the subjects and others, 4) importance of the
knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research
that involves human subjects and meets the criteria for one or more of
the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials.

Inclusion
of Women, Minorities, and Children. When
the proposed project involves clinical research, the committee will evaluate
the proposed plans for inclusion of minorities and members of both genders, as
well as the inclusion of children.

Vertebrate
Animals. The committee will evaluate the involvement
of live vertebrate animals as part of the scientific assessment according to
the following five points: 1) proposed use of the animals, and species,
strains, ages, sex, and numbers to be used; 2) justifications for the use of
animals and for the appropriateness of the species and numbers proposed; 3)
adequacy of veterinary care; 4) procedures for limiting discomfort, distress,
pain and injury to that which is unavoidable in the conduct of scientifically
sound research including the use of analgesic, anesthetic, and tranquilizing
drugs and/or comfortable restraining devices; and 5) methods of euthanasia and
reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards. Reviewers will assess whether materials or procedures proposed are
potentially hazardous to research personnel and/or the environment, and if
needed, determine whether adequate protection is proposed.

Resubmission
Applications. When reviewing a Resubmission
application (formerly called an amended application), the committee will
evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.

Renewal
Applications. Renewal applications are not permitted
for this FOA.

Revision
Applications. When reviewing a Revision application
(formerly called a competing supplement application), the committee will
consider the appropriateness of the proposed expansion of the scope of the
project. If the Revision application relates to a specific line of
investigation presented in the original application that was not recommended
for approval by the committee, then the committee will consider whether the
responses to comments from the previous scientific review group are adequate
and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable
for the project proposed, reviewers will address each of the following items,
but will not give scores for these items and should not consider them in
providing an overall impact/priority score.

Applications
from Foreign Organizations.
Foreign applications are not permitted for this FOA.

Select
Agents Research. Reviewers will assess the information
provided in this section of the application, including 1) the Select Agent(s)
to be used in the proposed research, 2) the registration status of all entities
where Select Agent(s) will be used, 3) the procedures that will be used to
monitor possession use and transfer of Select Agent(s), and 4) plans for
appropriate biosafety, biocontainment, and security of the Select Agent(s).

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NOA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section IV.5. Funding
Restrictions.

A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official.

A
final progress report, invention statement, and Financial Status Report are
required when an award is relinquished when a recipient changes institutions or
when an award is terminated.

Section VII. Agency
Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:

Human Subjects Protection:Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their
institutions, on issues related to institutional policies and
local IRB rules, as well as local, State and Federal laws and regulations,
including the Privacy Rule.

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088. For additional information,
see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH
recognizes the rights of grantees and contractors to elect and retain title to
subject inventions developed with Federal funding pursuant to the Bayh Dole Act
(see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators
submitting an NIH application or contract proposal, beginning with the October
1, 2004 receipt date, are expected to include in the application/proposal a
description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers to
benefit from the resources developed with public funding. The inclusion of a model
organism sharing plan is not subject to a cost threshold in any year and is
expected to be included in all applications where the development of model
organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to
place data collected under this funding opportunity in a public archive, which
can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description
of the archiving plan in the study design and include information about this in
the budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other human
subjects procedures given the potential for wider use of data collected under
this award.

Inclusion of Women And Minorities in Clinical
Research:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the
updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy
incorporates: the use of an NIH definition of clinical research; updated racial
and ethnic categories in compliance with the new OMB standards; clarification
of language governing NIH-defined Phase III clinical trials consistent with the
new PHS Form 398; and updated roles and responsibilities of NIH staff and the
extramural community. The policy continues to require for all NIH-defined Phase
III clinical trials that: a) all applications or proposals and/or protocols
must provide a description of plans to conduct analyses, as appropriate, to
address differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable; and b) investigators must report annual accrual and
progress in conducting analyses, as appropriate, by sex/gender and/or
racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them. All investigators proposing research involving
human subjects should read the "NIH Policy and Guidelines" on the
inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH
Public Access Policy Requirement:In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html),
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be
made publicly available no later than 12 months after publication. As of May
27, 2008, investigators must include the PubMed Central reference number when
citing an article in NIH applications, proposals, and progress reports that
fall under the policy, and was authored or co-authored by the investigator or
arose from the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable
Health Information:The Department of
Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).

Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the
Privacy Rule, including a complete Regulation Text and a set of decision tools
on "Am I a covered entity?" Information on the impact of the HIPAA
Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant
Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.

Healthy People 2010:The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372. Awards are made under the authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found
at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Loan Repayment Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.